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Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PACK, Model Number: DYNJ44847I; b. ABDOMINAL VASCULAR PACK, Model Number: DYNJ82578; c. ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C; d. ABLATION PACK, Model Number: DYNJ61957A; e. ACCESSORY OPEN HEART PACK, Model Number: DYNJ36600F; f. ADULT CORONARY PACK, Model Numbers: DYNJV0275J, DYNJV0275K, DYNJV0275L, DYNJV0275M; g. AFIB PACK, Model Number: DYNJ69682; h. ALT MINOR VASCULAR CDS, Model Number: CDS840493F; i. ANGIO-VASCULAR, Model Number: DYNJ24272C; j. ARM VASCULAR-LF, Model Number: DYNJ905290D; k. ARTERIAL/VENOUS ACCESS TRAY, Model Number: DYNDC3038; l. ARTERIOGRAM PACK, Model Numbers: DYNJ81636, DYNJ81636A; m. ARTERIOGRAM PACK 2, Model Number: DYNJ83051; n. AUD MAJOR VASC PK-LF, Model Number: DYNJ40728D; o. AUD MAJOR VASCULAR-LF, Model Number: DYNJ40728A, DYNJ40728B, DYNJ40728C; p. AV FIST PACK, Model Number: DYNJ83462; q. AV FISTULA, Model Numbers: DYNJ64143B, DYNJ905219B, DYNJ905219C, DYNJ905219D; DYNJ905219F, DYNJ906341D, DYNJ906945A, DYNJ907975, DYNJ907975B, DYNJ908096; r. AV FISTULA CAROTID PACK, Model Number: DYNJ82570; s. AV FISTULA PACK, Model Number: DYNJ52093J, DYNJ62218B, DYNJ66184A, DYNJ66184B, DYNJ67178A, DYNJ69443A, DYNJ69443B, DYNJ69443D, DYNJ69489A, DYNJ81033, DYNJ81605, DYNJ82477; t. AV FISTULA PACK-LF, Model Number: DYNJ64499B, DYNJ64499D, DYNJ69167A, DYNJ69167C; u. AV FISTULA VASCULAR, Model Number: DYNJ67340; v. AV GRAFT, Model Number: DYNJ903457D; w. AV GRAFT-LF, Model Number: DYNJ40077F; x. BAPTIST SOUTH OPEN HEART CV PK, Model Number: CDS983147F, CDS983147I; y. BEDSIDE PICC CDS, Model Number: CDS984642; z. BGMC CAROTID MAJOR VASCULAR, Model Number: DYNJ907339; aa. C V MAJOR PACK, Model Number: DYNJ64861A; bb. C V MINOR PACK, Model Number: DYNJ64862B; cc. CABG, Model Numbers: DYNJ906878A, DYNJ9372030F, DYNJ9372030G; dd. CABG HEART CDS, Model Number: CDS985384C; ee. CABG PACK, Model Numbers: DYNJ0408782AA, DYNJ53827, DYNJ59036B, DYNJ59036C, DYNJ59036D, DYNJ59036F; ff. CABG PACK NTX, Model Numbers: DYNJ68389, DYNJ68389A; gg. CARDIAC A B PACK-LF, Model Number: DYNJV0177AG; hh. CARDIAC A & B PACK-LF, Model Number: DYNJV0177AG; ii. CARDIAC CABG B, Model Numbers: DYNJ908121A, DYNJ908121B; jj. CARDIAC CABG PACK, Model Number: DYNJ903072R; kk. CARDIAC CATH PACK, Model Number: DYNJ41195D; ll. CARDIAC EP PACK-LF, Model Numbers: DYNJ0429185K, DYNJ0429185M; mm. CARDIAC ROBOT PACK, Model Number: DYNJ66254A; nn. CARDIOLOGY EP, Model Number: DYNJ59968; oo. CARDIOVASCULAR PT 2, Model Numbers: DYNJ905516C, DYNJ905516D, DYNJ905516F; pp. CAROTID DR WILLIAMS, Model Numbers: DYNJ906351B, DYNJ906351D; qq. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640A; rr. CAROTID PACK, Model Numbers: DYNJ0810062AI, DYNJ0810062AJ, DYNJ39488G, DYNJ66190A, DYNJ66190B, DYNJ66190C, DYNJ80346A; ss. CAROTID PACK-LF, Model Number: DYNJ57646C; tt. CAROTID SUPPLY PACK, Model Number: DYNJ81369; uu. CAROTID VASCULAR PACK, Model Number: DYNJ44927F; vv. CAROTID-LF, Model Number: CDS984764F, DYNJ901745K; ww. CATH LAB PACK, Model Number: DYNJ57735F; xx. CATH PACK, Model Number: DYNJ59830A; yy. CLOVIS CATH LAB PACK, Model Number: DYNJ62379A; zz. CT CABG-LF - IFCAP 7279, Model Number: DYNJC9258G; aaa. CUH OPEN HEART A B C - CDS, Model Number: CDS983202F, CDS983202G, CDS983202I; bbb. CUSTOM CARDIAC CABG, Model Number: DYNJ906108A, DYNJ906108B, DYNJ906108C; ccc. CV AAA PACK W AUX, Model Number: DYNJ65710A; ddd. CV CDS, Model Number: CDS985395D; eee. CVOR ANGIOGRAPHY PACK, Model Number: DYNJ83432; fff. CVOR ENDOVASCULAR PACK, Model Number: DYNJ64506A; ggg. CVP PACK, Model Numbers: DYNJ46359C, DYNJ46359D; hhh. DBD-ABDOMINAL VASCULAR-LF, Model Number: DYNJ905291C; iii. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F; jjj. DBD-ALT MINOR VASCULAR CDS, Model Number: CDS840493F; kkk. DBD-AV FISTUL

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·May 15, 2023

Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U; 5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C; 6) CARDIAC CATH PACK, Pack Number DYNJ61256A; 7) CARDIAC CATH PACK-LF, Pack Number DYNJ61527; 8) CARDIAC CATH PACK-LF, Pack Number DYNJ53642C; 9) CARDIOVASCULAR PACK LJ-LF, Pack Number DYNJ49635F; 10) CAROTID PACK, Pack Number DYNJ0810062AI; 11) CASTRO CABG-COMPONENT PACK, Pack Number DYNJ44857T; 12) CATH PACK, Pack Number DYNJ59830A; 13) CHOG CARDIAC CATH PACK, Pack Number SYNJ10304B; 14) CICC, Pack Number DYNJ53854A; 15) CMHP PACEMAKER PACK, Pack Number DYNJ30217G; 16) DR NACKMAN VEIN PACK, Pack Number DYNJ56235; 17) ENDOVASCULAR AAA PACK-LF, Pack Number DYNJ55482F; 18) EP DEVICE, Pack Number DYNJ65916B; 19) EP STUDY PACK-LF, Pack Number DYNJ38059A; 20) FHZ PACEMAKER PACK, Pack Number DYNJ36931D; 21) GV OPEN HEART PACK, Pack Number DYNJ60618C; 22) HEART CABG CDS, Pack Number CDS983376Q; 23) HEART DRAPE & SUPPLY PACK, Pack Number DYNJ65226; 24) HH ARTERIOGRAM PACK, Pack Number DYNJ59466A; 25) LEX OPEN HEART, Pack Number DYNJ900968I; 26) MAJOR VASCULAR PACK SAFETY, Pack Number DYNJ54738C; 27) NIR PACK, Pack Number DYNJ63892A; 28) OPEN HEART, Pack Number DYNJ904261B; 29) OPEN HEART, Pack Number DYNJ904261B; 30) OPEN HEART, Pack Number DYNJ905021J; 31) OPEN HEART A PACK, Pack Number DYNJ04478R; 32) OPEN HEART ACC, Pack Number DYNJ23533D; 33) OPEN HEART CDS, Pack Number CDS840171AB; 34) OPEN HEART DRAPE PACK-LF, Pack Number DYNJ0382048N; 35) OPEN HEART PACK, Pack Number DYNJ45122C; 36) OPEN HEART PACK, Pack Number DYNJ55648; 37) OPEN HEART PACK, Pack Number DYNJ04381J; 38) OPEN HEART PACK & BASIN SET-LF, Pack Number DYNJ24300M; 39) OPEN HEART PACK-LF, Pack Number DYNJ0369758N; 40) OPEN HEART PART B PACK, Pack Number DYNJ43038N; 41) OPEN HEART SUPPLY, Pack Number DYNJ65641; 42) OPEN PACK, Pack Number DYNJ67442B; 43) PACEMAKER, Pack Number DYNJ59399I; 44) PACEMAKER IMPLANT PACK-LF, Pack Number DYNJ0373237M; 45) PACEMAKER PACK, Pack Number DYNJ66165; 46) PACEMAKER PACK, Pack Number DYNJ41134B; 47) PACEMAKER PACK, Pack Number DYNJ61260A; 48) PACEMAKER PACK, Pack Number DYNJ60635; 49) PACEMAKER PACK, Pack Number DYNJ42602C; 50) PACEMAKER PACK 0121271-LF, Pack Number DYNJ32897J; 51) PACEMAKER PACK CV-LF, Pack Number DYNJ39912B; 52) PACEMAKER PACK-LF, Pack Number DYNJ53112B; 53) PACEMAKER PACK-LF, Pack Number DYNJ51844B; 54) PACEMAKER PACK-LF, Pack Number DYNJ0854874R; 55) PEDI EP PACK, Pack Number DYNJ54750G; 56) PERMANENT PACING PACK-LF, Pack Number DYNJ22036F; 57) PK, OPEN HEART, Pack Number DYNJ44015B; 58) PK, OPEN HEART-CABG, Pack Number DYNJ45048C; 59) RR-ADULT PUMP PACK-LF, Pack Number DYNJ0394805N; 60) RRMC CAROTID PACK-2, Pack Number DYNJ33544L; 61) RR-PEDIATRIC PUMP PACK-LF, Pack Number DYNJ0394730P; 62) TAVR PACK, Pack Number DYNJ58386A; 63) THORACIC PACK, Pack Number DYNJ80309; 64) VASCULAR, Pack Number DYNJ45376G; 65) VASCULAR PACK, Pack Number DYNJ48288C; 66) VASCULAR PACK, Pack Number DYNJ54979; 67) VASCULAR PACK, Pack Number DYNJ64883C; 68) VASCULAR PACK, Pack Number DYNJ43945I; 69) VASCULAR PACK, Pack Number DYNJ43945I; 70) VASCULAR PACK, Pack Number DYNJ67426A; 71) VASCULAR PACK WRO-LF, Pack Number DYNJ41863C; 72) VASCULAR SUB, Pack Number DYNJ60681A; 73) VASCULAR SUB, Pack Number DYNJ60681A

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·February 11, 2025

Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK, Pack Number CVI5065; 4) KT DR VELASCO FISTULA PACK, Pack Number DYNJ46648D; 5) PICC ABSCESS PACK-LF, Pack Number DYNJ0774005G; 6) PICC/RAD SPEC PROC 0906165-LF, Pack Number DYNJ32773G; 7) VAP PACK-LF, Pack Number PHS656578F

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFF·February 11, 2025

X-Guide Handpiece Adaptor Sleeve 3, Model P010727

FDA Recall
Open, Classified ·X-NAV Technologies, LLC·Product code QRY·March 4, 2024

X-Guide Handpiece Adaptor Sleeve 1, Model P010701

FDA Recall
Open, Classified ·X-NAV Technologies, LLC·Product code QRY·March 4, 2024

X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673

FDA Recall
Open, Classified ·X-NAV Technologies, LLC·Product code QRY·September 28, 2022

INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)

FDA Recall
Open, Classified ·Abbott Vascular·Product code MAV·March 11, 2022

Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01)

FDA Recall
Open, Classified ·Abbott Vascular·Product code MAV·March 11, 2022

20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)

FDA Recall
Open, Classified ·Abbott Vascular·Product code MAV·March 11, 2022

20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)

FDA Recall
Open, Classified ·Abbott Vascular·Product code MAV·March 11, 2022

20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)

FDA Recall
Open, Classified ·Abbott Vascular·Product code MAV·March 11, 2022

Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code MAV·August 5, 2025

20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).

FDA Recall
Open, Classified ·Abbott Vascular Inc·Product code MAV·November 6, 2024

20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.

FDA Recall
Open, Classified ·Abbott Vascular Inc·Product code MAV·November 6, 2024

20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures.

FDA Recall
Open, Classified ·Abbott Vascular Inc·Product code MAV·November 6, 2024

20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.

FDA Recall
Open, Classified ·Abbott Vascular Inc·Product code MAV·November 6, 2024